GeoVax Labs, Inc. has announced a significant shift in its clinical development strategy for Gedeptin®, focusing on its use as a neoadjuvant therapy in combination with pembrolizumab for patients with primary, resectable head and neck squamous cell carcinoma (HNSCC). This decision comes in the wake of the KEYNOTE-689 Phase 3 trial results, which showed a notable improvement in event-free survival with perioperative pembrolizumab in locally advanced HNSCC patients.
The new Phase 2 trial, AdPNP-203, will explore the efficacy of combining intra-tumoral Gedeptin®, intravenous fludarabine, and pembrolizumab in patients eligible for curative surgery. The trial aims to evaluate major pathological response and associated immunologic and biomarker outcomes, alongside event-free survival over a year. GeoVax's approach leverages Gedeptin's tumor-targeting and immune-sensitizing properties to enhance the effectiveness of checkpoint inhibitors within the tumor microenvironment.
Dr. Kelly McKee, GeoVax's Chief Medical Officer, emphasized the transformative potential of neoadjuvant checkpoint inhibition in head and neck cancer treatment, highlighting the goal of improving local tumor clearance and event-free survival, particularly for high-risk or PD-L1-low patients. David Dodd, Chairman and CEO of GeoVax, underscored the strategic nature of this shift, expressing confidence in Gedeptin's ability to enhance therapeutic outcomes when combined with systemic checkpoint inhibition.
The rationale behind this combination strategy is rooted in the observed benefits of neoadjuvant immunotherapy, as evidenced by the KEYNOTE-689 trial. Despite these advances, the persistence of local or distant relapse in some patients underscores the need for more intensive perioperative treatment approaches. Gedeptin's dual mechanism of action, combining cytotoxic effects with immune-priming capabilities, positions it as an ideal complement to checkpoint inhibitors, potentially converting immunologically 'cold' tumors into 'hot' targets for therapy.
Gedeptin, a gene-directed enzyme prodrug therapy, has received Orphan Drug Designation for oral and pharyngeal cancers and is supported by a strong intellectual property portfolio. GeoVax's innovative approach to immune-sensitizing therapies reflects a broader strategy to enhance the efficacy of checkpoint inhibitors and overcome tumor immune resistance across various solid tumor types.
